MAV · Class II · 21 CFR 870.1650

FDA Product Code MAV: Syringe, Balloon Inflation

Leading manufacturers include Merit Medical Systems, Inc., Boston Scientific Corp and Advanced Cardiovascular Systems, Inc..

57
Total
57
Cleared
120d
Avg days
1981
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Syringe, Balloon Inflation Devices (Product Code MAV)

57 devices
1–24 of 57
Cleared Apr 13, 2022
Everest 20 Inflation Device and 3-way Stopcock (AC2200)
K220773
Medtronic Vascular
Cardiovascular · 28d
Cleared Oct 20, 2016
Fluent inflation device
K162272
Vascular Solutions, Inc.
Cardiovascular · 69d
Cleared Apr 13, 2016
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
K153038
Medtronic, Inc.
Cardiovascular · 177d
Cleared Jan 20, 2016
basixTOUCH40 Inflation Syringe
K153672
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Dec 18, 2015
Fluent Inflation Device
K152387
Vascular Solutions, Inc.
Cardiovascular · 116d
Cleared Mar 05, 2015
MASTRO PLUS BALLOON IN-DEFLATION DEVICE
K140943
Beijing Demax Medical Technology Co.,Ltd
Cardiovascular · 325d
Cleared Jan 12, 2015
Presto Inflation Device
K143522
C.R. Bard, Inc.
Cardiovascular · 31d
Cleared Dec 12, 2014
SUMMED INFLATION DEVICE KIT
K133795
Sunny Medical Device (Shenzhen) Co., Ltd.
Cardiovascular · 364d
Cleared Apr 17, 2014
ENCORE 26 ADVANTAGE KIT
K140745
Boston Scientific Corp
Cardiovascular · 23d
Cleared Jun 19, 2013
BASIXTOUCH
K130566
Merit Medical Systems, Inc.
Cardiovascular · 107d
Cleared Dec 19, 2012
BASIXCONPAK ANALOG INFLATION SYRINGE
K122321
Merit Medical Ireland, Ltd.
Cardiovascular · 140d
Cleared Dec 14, 2012
OXTI INFLATION DEVICE
K122152
Oxti Corporation
Cardiovascular · 147d
Cleared Nov 13, 2012
ENCORE 26 ADVANTAGE KIT
K123214
Boston Scientific Corp
Cardiovascular · 29d
Cleared Apr 03, 2012
ENCORE 26 ADVANTAGE KIT
K120694
Boston Scientific Corp
Cardiovascular · 27d
Cleared Apr 18, 2005
DOLPHIN INFLATION DEVICE
K042449
Sedat S.A.
Cardiovascular · 221d
Cleared Feb 13, 2004
VICEROY INFLATION DEVICE
K040138
Merit Medical Systems, Inc.
Cardiovascular · 22d
Cleared Jan 22, 2002
VANGUARD REPROCESSED INFLATION DEVICES
K012480
Vanguard Medical Concepts, Inc.
Cardiovascular · 173d
Cleared Oct 25, 1999
INTELLISYSTEM II COLOR MONITOR
K993341
Merit Medical Systems, Inc.
Cardiovascular · 20d
Cleared Sep 12, 1996
INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)
K962495
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 78d
Cleared May 30, 1996
MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT
K960983
Medtronics Interventional Vascular
Cardiovascular · 80d
Cleared May 08, 1996
INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)
K961471
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 21d
Cleared Apr 17, 1996
USCI IDEAL PTCA KIT
K953522
Ryder Intl. Corp.
Cardiovascular · 265d
Cleared Mar 29, 1996
BREEZE DIGITAL INFLATION DEVICE
K953676
Namic
Cardiovascular · 235d
Cleared Mar 22, 1996
SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE
K955869
Scimed Life Systems, Inc.
Cardiovascular · 87d

About Product Code MAV - Regulatory Context

510(k) Submission Activity

57 total 510(k) submissions under product code MAV since 1981, with 57 receiving FDA clearance (average review time: 120 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.